Protocol summary
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Study aim
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Evaluation of the effectiveness of oral gabapentin on the use of sedative medications in patients undergoing mechanical ventilation in intensive care units in order to design a method for reducing the use of sedative medications in ICU
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Design
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In Imam Hossein Hospital, during a 6 month period we categorize all patients in ICU who are under mechanical ventilation and meet the inclusion criteria into two groups of intervention (administration of gabapentin) and control (placebo) based on block randomization
The present study is triple-blinded, so that the ICU nurse, the second ICU attending and the patient are not aware of the type of medication or placebo. To this end, the first ICU attending identifies eligible patients to be recruited into the study. The objectives of the study are explained to the patient's eligible family member and if they are willing to participate in the research project, written consent will be obtained from them.
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Settings and conduct
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This is a randomized 3-blinded clinical trial conducted at Imam Hossein Hospital.
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Participants/Inclusion and exclusion criteria
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Inclusion criteria: 1.patients with at least 18 years of age . 2. patients under mechanical ventilation for more than 3 days
Exclusion criteria: 1.Renal Disease 2. A history of acute neurological condition or neuromuscular disease. 3. haemodynamic instability
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Intervention groups
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In Imam Hossein Hospital, during a six month period we categorize all patients in ICU who are under mechanical ventilation and meet the inclusion criteria into two groups of intervention (administration of gabapentin) and control (placebo).
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Main outcome variables
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Midazolam and Fentanyl consumption
General information
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Reason for update
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The "expected recruitment start date" and consequently the "expected recruitment end date" were
written based on the code of ethics issuance date, while the start of patient recruitment was expected and organized to commence from 1st May 2019 which is after the issuance of IRCT Code . Therefore other related items were updated as well, namely the "Actual recruitment start date", "Actual recruitment end date", and "Trial completion date" respectively.
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Acronym
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IRCT registration information
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IRCT registration number:
IRCT20190202042588N1
Registration date:
2019-04-28, 1398/02/08
Registration timing:
prospective
Last update:
2020-02-04, 1398/11/15
Update count:
1
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Registration date
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2019-04-28, 1398/02/08
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Registrant information
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Recruitment status
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Recruitment complete
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Funding source
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Expected recruitment start date
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2019-05-01, 1398/02/11
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Expected recruitment end date
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2019-12-20, 1398/09/29
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Actual recruitment start date
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2019-05-01, 1398/02/11
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Actual recruitment end date
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2019-12-20, 1398/09/29
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Trial completion date
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2019-12-20, 1398/09/29
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Scientific title
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The effect of oral Gabapentin on sedative consumption in mechanically ventilated patients in intensive care unit
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Public title
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The effect of oral Gabapentin on sedative consumption in mechanically ventilated patients in intensive care unit
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Purpose
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Prevention
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Inclusion/Exclusion criteria
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Inclusion criteria:
1. Age should be ove18 years of age.
2. Mechanical ventilation for more than 3 days
Exclusion criteria:
1. Renal failure.
2. Acute neurological disease and Neuromuscular disease.
3. Unstable Hemodynamic
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Age
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From 18 years old to 70 years old
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Gender
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Both
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Phase
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3
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Groups that have been masked
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- Participant
- Care provider
- Investigator
- Outcome assessor
- Data analyser
- Data and Safety Monitoring Board
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Sample size
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Target sample size:
40
Actual sample size reached:
40
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Randomization (investigator's opinion)
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Randomized
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Randomization description
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The present study is a triple-blind study, so that the nurse of the department, the second assistant professor of ICU and the patient are not aware of the type of medication or placebo. To this end, firstly, by the first assistant professor of the ICU determines the patients eligible for inclusion in the study are by random numbers.
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Blinding (investigator's opinion)
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Triple blinded
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Blinding description
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And the relevant nurse will be given instructions on how to evaluate the sedation in each group. But he does not know the type of medicine. The second Assistant Professor of ICU assesses the patient's severity score, but does not know the type of medication.
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Placebo
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Not used
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Assignment
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Parallel
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Other design features
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Ethics committees
1
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Ethics committee
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Approval date
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2019-01-06, 1397/10/16
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Ethics committee reference number
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IR.SBMU.RETECH.REC.1397.836
Health conditions studied
1
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Description of health condition studied
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Dependence on respirator [ventilator] status
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ICD-10 code
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Z99.11
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ICD-10 code description
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Dependence on respirator [ventilator] status
Primary outcomes
1
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Description
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Fentanyl consumption
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Timepoint
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daily
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Method of measurement
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microgram/kilogram/hour
2
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Description
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Midazolam consumption
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Timepoint
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Daily
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Method of measurement
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milligram/kilogram
3
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Description
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Gabapentin prescribed dosage
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Timepoint
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Daily
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Method of measurement
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milligram
Secondary outcomes
1
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Description
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Number of days under ventilation
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Timepoint
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Daily
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Method of measurement
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Nursing Report
2
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Description
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Ramsay scale score
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Timepoint
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hourly
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Method of measurement
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Scale Score
Intervention groups
1
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Description
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Intervention group: In this group, the fixed dose of Gabapentin (300mg TDS, daily) dissolved in 5cc normal saline is administered through nasogastric tube , and then, if necessary, with the aim of maintaining an Ramsay Score Scale rating of between 2 and 3, fentanyl 0.5 - 2 μg / kg / hr) and midazolam (0.05-0.1 mg / kg) are given intravenously.
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Category
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Treatment - Drugs
2
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Description
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Control group: For the control group, the placebo solution which is dissolved in 5 ml of normal saline will be prescribed via NGT, and then, if necessary, with the aim of maintaining the rate of the RSS between 2 to 3, Fentanyl (0.5-2 μg / kg / hr) and Midazolam (0.05-0.1 mg / kg) will be prescribed intravenously
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Category
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Placebo
1
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Sponsor
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Grant name
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Grant code / Reference number
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Is the source of funding the same sponsor organization/entity?
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Yes
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Title of funding source
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Shahid Beheshti University of Medical Sciences
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Proportion provided by this source
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100
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Public or private sector
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Public
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Domestic or foreign origin
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Domestic
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Category of foreign source of funding
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empty
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Country of origin
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Type of organization providing the funding
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Academic
Sharing plan
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Deidentified Individual Participant Data Set (IPD)
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Yes - There is a plan to make this available
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Study Protocol
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No - There is not a plan to make this available
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Statistical Analysis Plan
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No - There is not a plan to make this available
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Informed Consent Form
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Undecided - It is not yet known if there will be a plan to make this available
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Clinical Study Report
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Yes - There is a plan to make this available
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Analytic Code
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Undecided - It is not yet known if there will be a plan to make this available
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Data Dictionary
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Undecided - It is not yet known if there will be a plan to make this available
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Title and more details about the data/document
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The whole potential data after being unidentifiable is published
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When the data will become available and for how long
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From 1400
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To whom data/document is available
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Medical Society
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Under which criteria data/document could be used
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Contributing to studies
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From where data/document is obtainable
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sarasalarian@sbmu.ac.ir
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What processes are involved for a request to access data/document
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two months
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Comments
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